Coronary Bifurcation Lesions Research Articles

Provisional Stenting Techniques Using A Novel Modified Jailed Balloon

Coronary bifurcation lesions are frequently found; account for one-fifth of all Percutaneous Coronary Interventions (PCI), and are considered as complex cases to treat. The provisional stenting strategy is thought of as the stenting of choice for most coronary bifurcation lesions. Still, it has a risk of side branch (SB) occlusion after the main vessel (MV) stenting. Several strategies have been proposed to overcome this challenge. Jailed balloon technique (JBT), first proposed by Burzotta et al. in 2010 was a more recent modification of jailed wire technique (JWT) to further decrease the risk for SB occlusion during crossover stenting in bifurcation lesion. Since then, certain modifications had been tested to the conventional jailed balloon technique to maximize SB protection during the provisional stenting strategy. We tried to make a mini case series of 6 patients with application of jailed ballon technique with some modifications in bifurcation lesion with provisional stenting strategy and evaluate its efficacy and safety, with quite satisfying results. Our novel JBT technique had some different characteristics from previous JBT techniques and aimed at simplifying the procedure while preserving side branch during crossover stenting.

Long-term outcomes of drug-eluting balloons for treatment of side branches in patients with true coronary bifurcation lesions

Background: Bifurcation treatments make up ca. 15–20% of coronary interventions. Despite the use of drug-eluting stents, the management of bifurcation lesions, especially with side branches involved, remains a challenge.Objective: To evaluate long-term clinical and angiographic outcomes after using a paclitaxel-coated balloon for the treatment of side branches in patients with true bifurcation lesions.Methods: Eighty patients with coronary artery disease were enrolled after true bifurcation lesion stenting. All patients were randomized at the 1:1 ratio to the group of main branches stenting followed by the dilatation of side branches with drug-eluting balloons and provisional stenting group.Results: Long-term results were analyzed after 12 months. The most common bifurcation lesion involved the left anterior descending artery and diagonal branch (57.5%). Late lumen loss in the side branch (0.51 ± 0.22 vs 0.33 ± 0.24 mm) and in both the bifurcation branches (main branch + side branch) (1.06 ± 0.29 vs 0.79 ± 0.27 mm) was significantly higher in the patients after provisional stenting.Overall postoperative incidence of major adverse cardiovascular events was 17.5% and 7.5% (p = 0.31) in the provisional stenting and drug coated balloon groups, respectively. Patients with drug-eluting balloons for the treatment of side branches had a more pronounced decrease in angina symptoms after 12 months. Multivariate analysis showed that diabetes mellitus (OR: 10.9) and glomerular filtration rate (OR: 0.95) were independent predictors of major adverse cardiovascular events in bifurcation interventions.Conclusion: Drug-eluting balloons for the dilatation of side branches after the stenting of main branches are superior to provisional stenting in terms of the late lumen loss. Received 31 August 2022. Revised 17 November 2022. Accepted 18 November 2022. Funding: The study did not have sponsorship. Conflict of interest: The authors declare no conflict of interest. Contribution of the authorsConception and study design: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovData collection and analysis: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoStatistical analysis: T.K. Eraliev, D.A. Khelimskii, A.G. BadoianDrafting the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. GorgulkoCritical revision of the article: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. KrestyaninovFinal approval of the version to be published: T.K. Eraliev, D.A. Khelimskii, A.G. Badoian, O.V. Krestyaninov, A.A. Baranov, A.P. Gorgulko

A novel hybrid strategy of drug coated balloon and stent for coronary bifurcation lesions

Background. Provisional side branch (SB) stenting strategy is the default approach for the majority of bifurcation lesions, but outcomes of SB is suboptimal. Though drug coated balloon (DCB) improving SB outcomes attracts an increasing attention, sequence of DCB hasn’t yet been determined. We presented a novel hybrid strategy of DCB and stent for bifurcation lesions. Methods. With lesion preparation, DCB was persistently inflated in SB kissing with main branch (MB) stent deployment and balloon post-dilation of the bifurcation core. Proximal optimization technique was performed strictly not exceeding the bifurcation. Procedural and clinical adverse events were evaluated. Canadian Cardiovascular Society (CCS) angina classification was assessed at baseline and clinical follow-up. Results. Fourteen patients undergoing the hybrid technique from August 2020 to July 2021 were enrolled. The technique was successfully performed in all patients without rewiring or SB compromise. Minimal lumen diameter of SB increased from 0.60 ± 0.40 mm to 2.1 ± 0.2 mm while the percent stenosis decreased from 72.4 ± 17.9% to 19.6 ± 4.7%. In addition, intravascular ultrasound indicated comparable stent symmetry index and incomplete stent apposition between proximal and distal segments of stent. No further intervention was performed, and mean fractional flow reserve of SB (n = 12) was 0.88 ± 0.05. No major adverse cardiac events was noted in hospital and 12-month follow up. The mean CCS angina score was reduced by 84% (2.2 vs 0.4, p < .001). Conclusion. The hybrid strategy facilitates treatment of DCB and stent for bifurcation lesions, which appears to be feasible and acceptable in a short-term follow-up.

Drug-Coated versus Uncoated Balloon for Side Branch Protection in Coronary Bifurcation Lesions Treated with Provisional Stenting Using Drug-Eluting Stents: A Meta-analysis.

Provisional stenting using drug-eluting stents (DES) has become the preferred treatment for coronary bifurcation lesions (CBLs). We performed a meta-analysis to compare the effects of side branch (SB) protection using a drug-coated balloon (DCB) versus an uncoated balloon (UCB) during the procedure. Relevant randomized and nonrandomized studies were identified by searching the Medline, Embase, Web of Science, Wanfang, and CNKI databases. We used a random-effect model to pool the data by incorporating the heterogeneity between the included studies. Overall, 803 patients with CBLs treated with provisional stenting using DES were included from seven studies. With a follow-up duration of 6 to 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): -11.35%, 95% confidence interval (CI): -14.17 to-8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: -0.19 mm, 95% CI:-0.28 to-0.10, p < 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.49, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p < 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results. For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.

Bifurcation strategies using second-generation drug-eluting stents on clinical outcomes in diabetic patients.

Diabetes mellitus (DM) is a critical risk factor for the pathogenesis and progression of coronary artery disease, with a higher prevalence of complex coronary artery disease, including bifurcation lesions. This study aimed to elucidate the optimal stenting strategy for coronary bifurcation lesions in patients with DM. A total of 905 patients with DM and bifurcation lesions treated with second-generation drug-eluting stents (DES) from a multicenter retrospective patient cohort were analyzed. The primary outcome was the 5-year incidence of target lesion failure (TLF), which was defined as a composite of cardiac death, target vessel myocardial infarction, and target lesion revascularization. Among all patients with DM with significant bifurcation lesions, 729 (80.6%) and 176 (19.4%) were treated with one- and two-stent strategies, respectively. TLF incidence differed according to the stenting strategy during the mean follow-up of 42 ± 20 months. Among the stent strategies, T- and V-stents were associated with a higher TLF incidence than one-stent strategy (24.0 vs. 7.3%, p < 0.001), whereas no difference was observed in TLF between the one-stent strategy and crush or culotte technique (7.3 vs. 5.9%, p = 0.645). The T- or V-stent technique was an independent predictor of TLF in multivariate analysis (hazard ratio, 3.592; 95% confidence interval, 2.117-6.095; p < 0.001). Chronic kidney disease, reduced left ventricular ejection fraction, and left main bifurcation were independent predictors of TLF in patients with DM. T- or V-stenting in patients with DM resulted in increased cardiovascular events after second-generation DES implantation. https://clinicaltrials.gov/ct2/show/NCT03068494?term=03068494&draw=2&rank=1, identifier: NCT03068494.

Effect of Clinical and Lesional Characteristics On Side Branch Compromise During Provisional Bifurcation Stenting

Background :One of the most serious side effects of percutaneous coronary intervention (PCI) for bifurcationlesions is major side branch (SB) blockage. PCI is used to treat coronary bifurcations lesions inabout 15-20% of cases. Because of the risk of SB compromise, PCI of coronary bifurcationlesions is frequently thought to be a difficult procedure.OBJECTIVE: The goal of this study was to investigate the clinical and lesional predictability ofsevere SB blockage during coronary bifurcation intervention.MATERIAL &amp; METHODS: It was a retrospective study performed at Cardiac CatheterizationLab, Punjab Institute of Cardiology, Lahore. It was a six months study from 15th April 2022 to14th Oct, 2022. 93 patients enrolled using non-probability sampling technique. Patients betweenthe ages of 30 and 70 of either gender, with coronary bifurcation lesions undergoing PCI and atleast one significant SB were included. Data was entered in the predesigned proforma. SPSSversion 24 was used to analyze our data.RESULTS: In our study a total of 93 patients were enrolled, the mean age of the cases was53.30 ± 1.12. There were 68 (73%) male and 25 (27%) females in our study. There were 52(56%) diabetic, 50 (54%) hypertensive, 63 (68%) smokers and 42 (45%) hypercholestrolemicpatients were present in our study. In our study 36 (39%) patients were found with family historyof CAD and 6 (7%) patients found with recent MI. LAD was most frequently utilized bifurcationlesion in our study. The mean of lesion length was 28.82 ± 10.91 in this study. SB angle was 41º-50º in most of the cases 20 (22%), side branch diameter stenosis post MV stenting was 70-75%in 40 (43%) cases. Medina classification 1,1,1 was found in 43 (46%) cases. In 62 (67%) casesno side branch jailing was observed. Side branch predilatation before MV stenting was found in72 (77%) cases. Need of stenting in SB was found in 60 (65%) cases. Most frequently usedtechnique for SB provisional stenting was DK crush and mini crush in this study.Keywords: Bifurcation Lesions, SB, PCI

Influence of different postballoon expansion procedures: A finite element analysis.

Postballoon expansion is considered as an appropriate procedure for adequate stent expansion for coronary bifurcation lesions. Two postballoon expansion procedures are currently recommended: proximal optimization technique (POT)/side/POT and POT/kiss/POT. However, the effects of the two postballoon expansion treatments are different. There is a lack of biomechanical study to quantify the difference. It is recognized that biomechanical factors influence the occurrence of Major Cardiovascular Adverse Events (MACE), which includes recurrent angina pectoris, acute myocardial infarction and coronary heart disease death. The current paper evaluated the two postexpansion strategies and quantified biomechanical parameters to provide a basis for clinical decisions. Based on the CT angiography (CTA) data of a patient diagnosed with coronary bifurcation lesions, a personalized coronary bifurcation lesion model was constructed, and the surgical procedure after two expansions was simulated. The POT/side/POT and POT/kiss/POT expansion procedures were analyzed from the perspective of biomechanics through finite element analysis. The biomechanics factors, including the percentage of stent malapposition and stent occlusion at the side branch (SB) opening, the stent ellipse index of proximal main vessel (PMV) segment, the minimum lumen area of the stent vessel segment and the stress distribution of the vessel wall, were used to quantify clinician concerns about factors affecting patient outcomes. The factors include stent adhesion, SB open stent occlusion, poor stent deformation, patency effect of vessel stenosis, and vessel wall damage. Both postexpansion procedures were successfully simulated. The malapposition rate during POT/side/POT was larger (1.2%vs. 0.42%) and stent occlusion at the SB opening from the cross-section perpendicular to the SB opening after the POT/side/POT procedure was 0.20%, compared with 0.00% after POT/kiss/POT. POT/kiss/POT produced a larger PMV segment stent ellipse index. Minimum lumen area after POT/side/POT was 5.6 mm2 and after POT/kiss/POT 5.9 mm2 . POT/kiss/POT produces an effect of greater vascular stress than POT/side/POT. Numerical simulations provide a quantitative analysis to inform clinicians of the differences between preoperative planning and surgical procedures. Biomechanical analysis of the differences between the two postexpansion strategies found that the POT/kiss/POT procedure resulted in better stent fit, less occlusion of the SB open stent and better vascular patency but also resulted in poor stent deformation and caused greater vessel wall stress. The current study informs rationales for clinical understanding of postexpansion strategies.

Current Evidence and Future Perspective for Coronary Bifurcation Stenting.

Coronary bifurcation lesions account for 15%-20% of all percutaneous coronary interven tions and are associated with greater procedural complexity and consequently at higher risk for cardiac adverse events. Early clinical trials in the interventional approach to bifurcation lesions supported provisional stenting. However, the most recent randomized studies have indicated potentially superior results using a double-kissing crush technique, particularly for unprotected distal left main bifurcation lesions. Moreover, many operators recently favor double-kissing mini-culotte, nanocrush, and double-kissing nanocrush stenting techniques for bifurcation lesions. In this review, we describe the traditional and novel bifurcation stenting techniques and the current evidence for each and review general principles for bifurcation percutaneous coronary intervention.

Prognostic Value of Logistic Clinical Syntax Score in Coronary Bifurcation Lesions Treated with Double Stent Technique

Introduction: In this study, we aimed to investigate the relationship between the preprocedural logistic clinical SYNTAX score (Log CSS) and major cardiovascular events (MACE) in patients with true bifurcation lesions who underwent revascularization with the double stent strategy. Patients and Methods: A total of 233 non-ST elevation myocardial infarction (NSTEMI) patients who underwent revascularization with a double stent strategy were retrospectively included in the study. Anatomical SYNTAX score (SS) and log CSS were calculated. The patients were divided into two groups according to the cut-off value determined by ROC analysis. The prediction of two-year MACE with Log CSS was evaluated. Results: MACE developed in 33.9% of patients with high Log CSS and 8.5% of patients with low Log CSS (p&lt; 0.001). In the Kaplan-Meier survival analysis, the long-term survival of the high Log CSS patients was significantly lower than the low Log CSS group (Log-rank p&lt; 0.001). In multivariate COX analyses, high Log CCS (HR= 3.781; 95% CI= 1.706-8.377; p= 0.001) was the strongest independent predictor of MACE. Conclusion: Log CSS can be a simple and useful tool to predict the development of MACE in patients with true bifurcation lesions revascularized by percutaneous coronary intervention.

Provisional Vs Dual Stenting of Left Main Coronary Artery Bifurcation Lesions

Background: The primary LMCA stenting methods used nowadays consist of single stent (provisional), and two stent (T and protrusion, and double kissing crush {DK crush}, culotte, or classic crush). The optimal technique for bifurcation lesion treatment for the patients present with distal ULMCA disease is still unclear and not much is known about the best course of action and the clinical outcomes following various PCI techniques for ULMCA bifurcations in Pakistan. Objective: To investigate the midterm (3-year) outcomes related to the provisional stenting compared to two-stenting technique for the bifurcations of ULMCA undergoing the percutaneous coronary intervention. Methodology: A single-center retrospective, non-randomized cohort study was conducted during the period from March 2021 to August 2022 including all the consecutive LM bifurcation lesions. The patients attending Punjab Institute of Cardiology, Lahore were divided into two groups, depending upon the treatment received. One group underwent PCI with provisional stenting technique while the other underwent 2-stent PCI. The groups were compared for procedural success and 3-year clinical outcomes. Data was analyzed using SPSS. Results: The success rate of left main bifurcation angiography was comparable between both the techniques (2-stent 93.6 % vs. Provisional 92.1 %, P = 0.62). MACE rates were comparable between groups at 1, 2, and 3 years (PS 3.0 % vs. Dual stent 2.4 %, p = 0.75 at 1-year, PS 4.8 % vs. Dual stent 8 %, p = 0.26 at 2-years, and PS 10.2 % vs. Dual stent 12 % at 3-years, p = 0.62). Conclusion: Two stenting strategy was linked to same rates of MACEs at the 3-year duration in comparison to the single stenting technique (PS 10.2 % vs. 2-Stent 12 %, p=0.62) and both the dual and single provisional stent techniques have comparable angiographic success rate for LM bifurcation lesions.

Left Main Coronary Artery Bifurcation Lesions: Two Stents vs One Stent Strategy-Comparison of Major Adverse Cardiac Events (MACE) at 2 years

Objective: To evaluate the long-term clinical results for a one-stent (1S) strategy compared to a two-stent (2S) strategy in distal unprotected left main coronary artery (ULMCA) bifurcation disease.&#x0D; Study Design: Comparative Cross-sectional study.&#x0D; Place and Duration of Study: Armed Forces Institute of Cardiology, Rawalpindi Pakistan, from Jan 2019 to Apr 2020.&#x0D; Methodology: 1-S approach was defined as stenting of the main vessel only and 2-S approach as stenting side branch and main vessel. Individual undergoing LMCA intervention were included via consecutive sampling in the study. Stent Crossover approach was used in 1-S technique; whereas, DK crush, culotte, and T-stenting approaches were employed in individuals who were treated with a 2-S approach. A composite of major adverse cardiovascular event (MACE) i.e., myocardial infarction, stroke or death and target lesion revascularization (TLR) were considered as primary end-point.&#x0D; Results: A sum of 110 individuals were inducted, 74 of them had stenting of left main bifurcation using a 1-S approach; and 36 patients underwent a 2-S PCI. Average age of the patients included in the study was 63.9±10.8 years. In 1 stent subset, the success rate of procedure was 99% whereas 100% success rate was seen in 2-S group. During the 2-year duration of follow up,frequency of MACE in single stent subset was (5.4%) whereas it was (13.8%, p=0.253) in the 2-S subset.&#x0D; Conclusion: When compared to 2-S approach of distal left main stenting, a 1-S strategy appears to demonstrate optimal clinical results and 2-year survival free of MACE. Choosing appropriate interventional strategy has proven prognostically significant; so, it demands mindful approach selection.

Jailed pressure wire technique for coronary bifurcation lesions: structural damage and clinical outcomes

Introduction and objectivesThe use of a pressure wire as a jailed wire to evaluate side branch results during provisional stenting seems feasible. However, safety concerns exist due to the mechanical damage of the wire and the lack of prospective data evaluating the prognosis of patients treated using this technique. This study sought to evaluate the structural damage of the pressure wire in patients treated using the jailed pressure wire technique and to assess mid-term clinical outcomes. MethodsWe enrolled 99 patients with single bifurcation lesions and provisional stenting as the strategy of choice. A jailed pressure wire was used to guide side branch intervention according to the instantaneous wave-free ratio (iFR). A total of 114 patients and the respective nonpolymer-coated jailed wires were used as historical controls. Guidewire damage was evaluated by stereomicroscopy. The primary endpoint was significant microscopic damage. Major adverse cardiac events were evaluated at 2-year follow-up. ResultsSignificant microscopic damage was more frequent in pressure wires than in nonpolymer-coated wires (53.5% vs 22.8%, P<.001). There were no fractures in either group. There were fewer side branch interventions in the pressure wire group (postdilation/kissing balloon, 32.3% vs 56.1%, P=.001; stenting, 0.0% vs 2.6%, P=.104). The 2-year rate of major adverse cardiac events was similar between the 2 groups (HRadj, 0.42; 95%CI, 0.10-1.73; P=.229). ConclusionsPressure wires were less resistant to jailing than conventional nonpolymer-coated wires. Patients treated with iFR-guided provisional stenting required fewer side branch interventions but had similar 2-year clinical outcomes than patients treated with the angiography-guided technique.

Multimodality imaging results of TAP versus novel modified TAP stenting in coronary bifurcation: From bench testing to first-in-man investigation.

We investigated the results of T and small protrusion (TAP) versus a novel modification of TAP (mTAP) stenting by multimodality imaging in bench testing and in patients with coronary bifurcation lesions (CBL). TAP stenting is a suboptimal technique for bailout side branch (SB) stenting. In a bench model, optical coherence tomography (OCT), microscopic examinations (ME), and computational fluid dynamics (CFD) were performed after TAP and mTAP stenting. In 20 patients with CBL, 80 intravascular ultrasound(IVUS) examinations were performed during mTAP stenting in which the SB stent was pulled-back to indent the inflated main vessel (MV) balloon and deployed while deflating it. For TAP stenting, the tip of the SB stent was positioned in the MV and deployed. In bench testing, OCT showed neocarina length (NL) was shorter and minimum stent area (MSA) was larger after mTAP versus TAP stenting (2.84 ± 0.70 vs. 4.80 ± 020 mm; 6.75 ± 1.50 vs. 4.5 ± 2.2 mm2 ; respectively; p < 0.05). By ME, NL was shorter and shear rate trended lower after mTAP versus TAP stenting. In patients, IVUS showed MSA was larger after versus before mTAP stenting (6.32 ± 0.58 vs. 5.21 ± 0.56 mm2 ; p < 0.01); NL was 1.43 ± 0.22 mm with SB ostium coverage. The Seattle Angina questionnaire (SAQ) score was higher at 6 months versus baseline (85 ± 4.0 vs. 48 ± 6.0, respectively; p < 0.001). This multimodality imaging study showed, for the first time, mTAP stenting resulted in larger stent area and shorter neocarina than TAP stenting in bench testing. In patients with CBL, mTAP stenting led to larger stent area, short neocarina with complete SB ostium coverage, and improved the SAQ score at follow-up.

EPIC03-BIOSS observational prospective study. Performance analysis of the BIOSS LIM C dedicated stent in coronary bifurcation lesion angioplasty

EPIC03-BIOSS observational prospective study. Performance analysis of the BIOSS LIM C dedicated stent in coronary bifurcation lesion angioplasty

Drug-coated balloon in the treatment of coronary left main true bifurcation lesion: A patient-level propensity-matched analysis.

An increasing body of evidence suggests that drug-coated balloon (DCB) angioplasty represents a valuable option for revascularization in selected patients with coronary bifurcation disease. However, there remains a paucity of real-world observational evidence on the efficacy of DCB in left main (LM) true bifurcation lesion. We compared clinical and angiographic outcomes of hybrid [DCB + drug-eluting stent (DES)] versus DES-only strategy (provisional stenting or two-stent strategies) in de novo LM true bifurcated lesions. The primary endpoint was the 2-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularization (CD-TLR). A routine 1-year angiographic follow-up was scheduled. Propensity-score matching was utilized to assemble a cohort of patients with similar baseline characteristics. Among 1077 eligible patients, 199 who received DCB treatment and 398 who were assigned to DES therapy had similar propensity scores and were included in the analysis. TLF within 2 years occurred in 13 patients (7.56%) assigned to DCB group, and 52 patients (14.36%) assigned to DES group (odds ratio: 0.487; 95% confidence interval: 0.258-0.922; P = 0.025; Log-rank P = 0.024). Compared with the DES group, the DCB group resulted in a lower rate of CD-TLR (2.91% vs. 9.42%; P = 0.007). Cardiac death, TVMI, all-cause mortality, and stent thrombosis were comparable between both groups. Patients treated with DES-only were associated with a higher late lumen loss (0.42 ± 0.62 mm vs. 0.13 ± 0.42 mm, P < 0.001) compared with the DCB group at 1 year. In sensitivity analysis, the DCB group also presented a lower incidence of TLF, CD-TLR and stent thrombosis both compared to the two-stent strategy and compared to provisional stenting (Ps < 0.05). The 2-year results of PCI utilizing DCB for LM true bifurcation lesions are superior to employing DES alone in terms of safety and effectiveness.

Efficacy and safety of drug-coated balloon combined with cutting balloon for side branch of true coronary bifurcation lesions: Study protocol for a multicenter, prospective, randomized controlled trial.

Coronary bifurcation lesions are common of percutaneous coronary intervention (PCI), and the optimal interventional therapy strategy is still a matter of debate and remains a challenge for interventional cardiologists. The provisional stenting technique is still a preferred method for most bifurcation lesions, but restenosis of the side branch (SB) occurs in approximately 17-19% of cases. Therefore, the dilemma of reducing SB restenosis still exists, and further research on strategies to reduce restenosis for SB is necessary. Drug-coated balloon (DCB) can reduce clinical events in small vessel disease and in-stent restenosis. The efficacy and safety of DCB for SB of true coronary bifurcation lesions have not been fully investigated. A randomized comparison of DCB combined with cutting balloon angioplasty vs. cutting balloon angioplasty for SB has never been published. The purpose of this study is to explore the superiority of DCB combined with cutting balloon vs. cutting balloon angioplasty for SB after main vessel (MV) drug-eluting stent implantation of true coronary bifurcation lesions. This study is a multicenter, prospective, randomized controlled trial including 140 patients with true coronary bifurcation lesions. Patients will be randomized in a 1:1 manner to receive either DCB combined with cutting balloon or cutting balloon angioplasty for SB after MV drug-eluting stent implantation. The primary endpoint is the evaluation of late lumen loss (LLL) of SB at the 9-month follow-up. The secondary endpoints include procedural success during initial hospitalization, LLL of MV at the 9-month follow-up, binary angiographic restenosis in MV and SB at the 9-month follow-up, the proportion of patients with a final post-PCI quantitative flow ratio result ≤ 0.80 for SB at the 9-month follow-up, and major adverse cardiac events during the 24-month follow-up. This clinical trial will provide evidence as to whether DCB combined with cutting balloon for SB of true coronary bifurcation lesions is a superior treatment approach. ChiCTR2000040475. The results of this clinical trial will be published in a peer-reviewed journal.

Safety and Efficacy of Bioresorbable Vascular Scaffolds in Coronary Bifurcation Lesions: A Systematic Review and Meta-Analysis.

Coronary bifurcation lesions (CBL) are one fifth of all coronary lesions and they do not have an optimal strategy for stenting yet. Bioresorbable scaffolds (BRS) are novel inventions proposed to be the optimal solution. The aim of this systematic review was to assess the role of BRS in treating CBL by comparing it to dedicated bifurcation stents (DBS). A systematic review was conducted following the PRISMA guidelines, searching databases such as ScienceDirect, EMBASE, MEDLINE, NIH, TRIP, PUBMED, and ClinicalTrials. gov. The risk of bias was assessed by MINORS and modified Cowley's criteria. Q statistic was used for heterogeneity testing and a meta-analysis was conducted using the "meta" package in the R software application. Fourteen studies were included with an average follow-up period of twelve months. Almost 80% of the participants were male (p-value= 0.148) and around two-thirds were smokers. Meta-analysis was performed for myocardial infarction (MI), target lesion revascularisation (TLR), major adverse cardiac events (MACE), and stent thrombosis (ST). These showed statistically nonsignificant differences, with a slight trend favouring BRS except with stent thrombosis. There is a lack of randomised trials on the topic, which may be an area for further research. But the results showed favourable yet statistically insignificant outcomes for BRS except for ST, an issue that can be addressed with technological advancement.

Provisional Versus Dual Stenting of Left Main Coronary Artery Bifurcation Lesions (from a Comprehensive Meta-Analysis)

The optimal technique for bifurcation of left main coronary artery (LMCA) stenting has been a subject of controversy since the inception of drug-eluting stents. We searched PubMed, Clinical Trials Registry, and the Cochrane Central Register of Controlled Trials from January 2002 through October 2021. A total of 13 studies comparing the use of provisional versus dual stenting in patients with LMCA bifurcation lesions were included. Any major adverse cardiac event (MACE) was considered the primary composite end point. The secondary end points included individual components of MACE, including death, myocardial infarction, and target lesion revascularization. The treatment effect was defined as the log odds ratio (OR) of provisional over dual stenting for cumulative event rate at 3 years. In 12 studies with 8,377 patients included for MACE, the use of a provisional-stenting strategy was associated with a significant reduction of 3-year MACE (OR 0.64, 95% confidence interval [CI] 0.46 to 0.88) compared with a dual-stenting strategy, primarily driven by target lesion revascularization (OR 0.51, 95% CI 0.36 to 0.73). No significant difference was found regarding death (OR 0.88; 95% CI 0.65 to 1.21) or myocardial infarction (OR 0.97, 95% Cl 0.61 to 1.54). In conclusion, our meta-analysis suggests that provisional stenting should be the preferred technique over dual stenting when treating LMCA bifurcation lesions with drug-eluting stents. Further randomized controlled studies compounded with intracoronary imaging comparing the 2 strategies are warranted.

Provisional stenting with side branch rescue stenting is associated with increased 3-year target lesion failure in patients with acute coronary syndrome and coronary bifurcation lesions.

BackgroundProvisional stenting (PS) is the main treatment for a majority of coronary bifurcation lesion and includes PS with 1-stent and PS with 2-stent. However, the treatment difference between PS with 1-stent and with 2-stent remains unclear in patients with the acute coronary syndrome (ACS) and coronary bifurcation lesions.Materials and methodsOverall, 820 ACS patients with Medina 1,1,1 or 0,1,1 coronary bifurcation lesion who had completed 3-year follow-up were included and assigned to the PS with 1-stent (n = 519) or the PS with 2-stent (n = 301) according to the use of final stenting technique. The primary endpoint was the target lesion failure (TLF) at 3 years since stenting procedures.ResultsAt 3-year follow-up, TLF occurred in 85 (16.4%) patients in the PS with 1-stent group and 69 (22.9%) in the PS with 2-stent group (hazard ratio [HR] 1.52, 95% confidence interval [CI] 1.06–2.17, p = 0.021), mainly driven by a higher rate of target lesion revascularization (TLR) in the PS with 2-stent group (13.0% vs. 8.3%, HR 1.65, 95% CI 1.04–2.61, p = 0.033). Complex bifurcations, side branch (SB) pretreatment, intravascular imaging guidance, and hyperlipidemia were the four predictors for 3-year TLF. SB pretreatment was associated with increased 3-year TLR, leading to an extremely higher 3-year TLF.ConclusionProvisional with 2-stent for patients with ACS is associated with a higher rate of 3-year TLF, mainly due to increased requirement of revascularization. SB pretreatment should be avoided for simple bifurcation lesion.

Provisional Technique for Bifurcation Left Main In-Stent Restenosis Lesion: A Case Report

Background: Percutaneous coronary intervention for bifurcation lesions remains challenging because of its complexity and the lack of trials to guide decision-making. It also comes with several debatable issues, including the requirement for kissing balloon inflation as the post-dilation produces. Case Illustration: A 64-year-old male with some coronary risk factors of hypertension, passive smoker, and family history of CAD presented with recurring exertional chest pain for the last 4 months. He was hospitalized to undergo DCA-Adhoc after the ECG stress test revealed a positive result. The coronary angiography revealed a 95% ISR in the osteal LAD and 20% ISR of the proximal LCx. Since the patient refused to undergo coronary bypass surgery, the team decided to perform catheter intervention to the LM bifurcation of LAD-LCx. The procedure begins with the insertion of IABP through the access of the left femoral artery. We performed a provisional approach with the main vessel stenting of LM-LAD. At the end of the procedure, we performed simultaneous kissing balloon inflation of LAD-LCx followed by POT in LM stent as the post-dilation produces. Discussion: When considering intervention on a bifurcation lesion, there are two general strategies i.e the more conservative or provisional technique that intent to only use one stent and the two-stent approach. The provisional technique is considered to offer advantages in terms of reducing procedure complexity, reducing fluoroscopic time, requiring less contrast volume, and reducing resource (stent) use compared by 2 stent strategy. Conclusion: Coronary bifurcation lesions are fairly frequent, and their management is associated with an increased risk of MACE, increased complexity, and prolonged treatment times.